Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-22 @ 11:42 AM
Study NCT ID:
NCT04268095
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2020-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Operative Dressing After Clean Elective Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D045888', 'term': 'Ganglion Cysts'}], 'ancestors': [{'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-03', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Instrumental activities of daily living questioner (IADL)', 'timeFrame': 'Baseline (Pre-op), 2 weeks, 6 weeks, 3 months', 'description': 'Subjective function questioner. Scale 0-18. Higher score - better outcome.'}, {'measure': 'Change in Vancouver Scar Scale', 'timeFrame': '2 weeks, 6 weeks, 3 months', 'description': 'Evaluation of skin healing and scar formation. Scale 0-14. Higher score - inferior outcome.'}, {'measure': 'Change in quick Disability of the Arm, Shoulder and Hand questioner (DASH)', 'timeFrame': 'Baseline, 2 weeks, 6 weeks, 3 months', 'description': 'Subjective function questioner. Scale 0-100. Higher score - inferior outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger Disorder', 'Carpal Tunnel Syndrome', 'Ganglion']}, 'descriptionModule': {'briefSummary': "Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Nevertheless, the functional impairment due to a dressing in the hand is much greater than anywhere else, due to the constant use of hands in daily life activities. Yet, habits differs widely following surgeon's preference, from daily change with application of an antimicrobial unguent, to unchanged dressing until the first follow up consultation after 2 weeks, to complete removal of the dressing and basic soap and water cleaning at postoperative day (POD) 1. Those varying recommendations have functional and logistical implication for the patients, especially the elderlies, for whom autonomy is a fragile status that can be dramatically impaired by such protocols. The goal of this study is to define which post operative dressing protocol is optimal in terms of wound complications (disunion, infection)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Elective hand surgery with clean wound (Type 1 in wound classification of american college of surgeon 11) - (Carpal tunnel, trigger finger, cyst removal or foreign body removal, tendon release).\n\nExclusion Criteria:\n\n* Insertion of hardware\n* Known skin condition disturbing normal healing,\n* Immunodeficiency,\n* Incapacity to understand or to observe the self cleaning protocol.\n* Unexpected peroperative complication leading to a modification of the operative technique.'}, 'identificationModule': {'nctId': 'NCT04268095', 'briefTitle': 'Post Operative Dressing After Clean Elective Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv Medical Center'}, 'officialTitle': 'Post Operative Dressing After Clean Elective Hand Surgery', 'orgStudyIdInfo': {'id': '0548-18-TLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No dressing change', 'description': 'Patients do not change dressing from procedure to first clinic followup after 14 days.', 'interventionNames': ['Other: Dressing protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Ambulatory dressing change', 'description': 'Patients change dressing by an ambulatory nurse (not associated with the study) 2 times a week from surgery to first clinic followup after 14 days', 'interventionNames': ['Other: Dressing protocol']}, {'type': 'EXPERIMENTAL', 'label': 'No dressing', 'description': 'Patients take off dressing at post operative day 1 and clean it 3 times per day as instructed.', 'interventionNames': ['Other: Dressing protocol']}], 'interventions': [{'name': 'Dressing protocol', 'type': 'OTHER', 'description': 'Patients are assigned with different postoperative dressing protocols.', 'armGroupLabels': ['Ambulatory dressing change', 'No dressing', 'No dressing change']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6423906', 'city': 'Tel Aviv', 'state': 'IL', 'country': 'Israel', 'facility': 'Tel Aviv medical cemter', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '30 days', 'ipdSharing': 'YES', 'description': 'Data will be shared at the discretion of the Chief Investigator', 'accessCriteria': 'at the discretion of the Chief Investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Itay Ashkenazi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Itay Ashkenazi', 'investigatorAffiliation': 'Tel Aviv Medical Center'}}}}